UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040844 |
|---|---|
| Receipt number | R000046633 |
| Scientific Title | Comparison of diagnostic sensitivity of peroral cholangioscopy-guided target biopsy with that of transpapillary forceps biopsy under fluoroscopic guidance in patients suspected with bile duct cancer: A multicenter retrospective cohort study |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2021/08/06 17:57:52 |
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Basic information
Public title
Comparison of diagnostic sensitivity of peroral cholangioscopy-guided target biopsy with that of transpapillary forceps biopsy under fluoroscopic guidance in patients suspected with bile duct cancer: A multicenter retrospective cohort study
Acronym
POCS- vs ERCP-guided biopsy
Scientific Title
Comparison of diagnostic sensitivity of peroral cholangioscopy-guided target biopsy with that of transpapillary forceps biopsy under fluoroscopic guidance in patients suspected with bile duct cancer: A multicenter retrospective cohort study
Scientific Title:Acronym
POCS- vs ERCP-guided biopsy
Region
| Japan |
Condition
Condition
bile duct cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the diagnostic ability of peroral cholangioscopy-guided target biopsy for biliary stricture suspected with bile duct cancer by comparing that of conventional endoscopic transpapillary forceps biopsy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic sensitivity
Key secondary outcomes
accuracy, specificity, positive predictive value (PPV), negative predictive value (NPV), sample size, and sample quality
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suspected with bile duct cancer who underwent biopsy under both fluoroscopy and cholangioscopy guidance in same session at University of Toyama,Gifu University, and Teikyo University Mizonokuchi Hospital between November 2013 and February 2020.
Key exclusion criteria
1. Patients with pancreatic head mass and with dialation of upstream main pancreatic duct
2. Patients with exposure of tumor at duodenal papilla
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yasuda |
Organization
University of Toyama
Division name
Third Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7300
yasudaic@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Yasuda |
Organization
University of Toyama
Division name
Third Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7300
Homepage URL
yasudaic@med.u-toyama.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine, University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Third Department of Internal Medicine, University of Toyama
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
First Department of Internal Medicine, Gifu University Hospital and Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Reserch in Toyama University Hospital
Address
2630 Sugitani, Toyama 930-0194
Tel
076-415-8857
rinri@adm.u-toyama.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
富山大学附属病院（富山県）、岐阜大学医学部附属病院（岐阜県）、帝京大学溝口病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 06 | Month | 21 | Day |
Last modified on
| 2021 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046633
